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EMA reviewing Biogen’s potential Alzheimer’s drug for use in the EU

Biogen and Eisai filed aducanumab for market approval with the FDA in August


The European Medicines Agency (EMA) has accepted Biogen and Eisai’s application to review aducanumab, a potential Alzheimer’s drug, for use in the EU. Regulators will need to approved the drug before it could be made more widely available.

People with Alzheimer’s experience a build-up of the protein amyloid in their brains at an early stage in the disease process. Aducanumab is an antibody designed to target this protein.

In May 2019, phase 3 clinical trials of aducanumab, ENGAGE and EMERGE, were halted by the pharmaceutical company Biogen after early indications suggested the drug would not be beneficial for those in the early stages of Alzheimer’s disease.

A larger amount of data that became available after the trials stopped led to new analysis, however, and resulted in Biogen filing for market approval with the Food and Drug Administration (FDA) in August.

Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrated that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease.

The proposal was accepted by the FDA under their priority review process and a decision is expected by March 2021.

Following the EMA’s acceptance of the application to review the drug for use in people with Alzheimer’s disease in the EU, Biogen is planning to make the drug available to eligible participants from their earlier trials of aducanumab, as part of a new study.

“Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease,” said Michel Vounatsos, Chief Executive Officer at Biogen.

“There are no treatments available that impact the progression of Alzheimer’s disease by addressing the underlying disease pathology. The potential that aducanumab may hold to effectively reduce the clinical decline brings new hope to people and families living with this devastating disease,” said Haruo Naito, Chief Executive Officer at Eisai Co, Ltd.

Article by
Iona Everson

2nd November 2020

From: Regulatory



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